On May 27, 2021 Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIRTM and ADAPTIR-FLEXTM platform technologies reported that the company has initiated the expansion phase of lead anti-leukemia drug candidate, APVO436, in adult patients with acute myeloid leukemia (AML) with a multi-center, multi-arm trial using the active recommended dose identified in the dose escalation phase (Part 1) of the study (Press release, Aptevo Therapeutics, MAY 27, 2021, View Source [SID1234583271]). During Part 1, APVO436 exhibited a manageable side effect profile, encouraging single agent activity and a promising benefit to risk profile in relapsed AML patients. The Company has plans to submit data from the dose escalation phase for publication later this year.

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The dose expansion phase (Part 2), has been rationally designed to further evaluate the tolerability and clinical impact potential of APVO436 for indications of unmet and urgent medical need. During Part 2, the dose expansion phase of the study, a total of 90 AML patients will be enrolled into 5 cohorts of 18 patients each, as explained in the detailed and publicly available study information provided at CinicalTrials.gov (NCT03647800) The study will be conducted under an FDA-approved IND and has been Central IRB-approved. Patient enrollment is anticipated to commence in June. The goal of the expansion phase is to evaluate the safety and tolerability of APVO436 at the recommended Phase 2 dose level, when it is used as an adjunct to the standard of care and to obtain a preliminary assessment of the anti-leukemia activity of APVO436 containing experimental monotherapy and combination therapy modalities.

Protocol-specific training has started for the participating academic cancer centers in the US. Aptevo is planning to conduct Part 2 of the study at up to 20 clinical trial sites.

"The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen" explained Dr. Fatih Uckun, leukemia expert and Chief Clinical Advisor. "By combining APVO436 with the standard of care, Aptevo hopes to develop an innovative approach that improves outcomes for patients with relapsed AML, who generally have a dismal prognosis," he stated.

Dr. Uckun explained further: "In addition, newly diagnosed AML patients with inherent drug resistance who have documented residual leukemia after standard frontline chemotherapy regimens, have a very poor prognosis and are in urgent need of therapeutic innovations. Part 2 of the Aptevo study will therefore seek proof of concept in the use of APVO436 as part of frontline multimodality regimens would enable the eradication of residual leukemia cells that have escaped standard chemotherapy. To this end we will carefully study the tolerability and clinical activity of APVO436 when used as rationally designed in each of the 5 cohorts of Part 2 of our Phase 1B study."

Overview of Cohorts

In Cohort 1, AML patients in relapse will be treated with the standard chemotherapy drug cytarabine or the standard chemotherapy triple drug combination MEC (mitoxantrone, etoposide, cytarabine) plus APVO436. Also treated in this cohort will be patients with primary refractory AML whose leukemia failed to respond to frontline standard induction chemotherapy.

In Cohort 2, AML patients in first relapse will receive a combination of APVO436 + venetoclax + azacitidine. Also included in this cohort will be newly diagnosed AML patients with a poor prognosis who will receive this novel combination as their frontline induction regimen.

In Cohort 3, AML patients with poor prognosis who are newly diagnosed will receive their frontline chemotherapy to induce a remission and APVO436 will be added if there is evidence of residual leukemia remaining. Also included in this cohort will be AML patients who experienced an early first relapse within 1 year of receiving their frontline chemotherapy. Such patients are generally known to have a dismal outcome.

In Cohort 4, AML patients in 1st remission who have evidence of residual leukemia, also known as minimal residual disease (MRD), will receive the standard drug oral azacytidine in combination with APVO436.

In Cohort 5, AML patients in 2nd remission who are MRD+ will be treated with APVO436 monotherapy.

"New treatments are urgently needed for frontline adverse risk and relapsed AML populations and I look forward to working with Dr. Uckun and other investigators for a step-wise evaluation of the clinical potential of APVO436", says Dr. Justin Watts, Associate Professor of Medicine at the University of Miami Sylvester Comprehensive Cancer Center.

"This week has been exciting for Aptevo, as we announced both positive results from the dose escalation part of our Phase 1 trial and the initiation of the expansion phase. We are particularly excited about the fact that APVO436 did not cause severe neutropenia in any of the AML patients treated so far. This is a potentially paradigm-shifting discovery as it provides the unique opportunity to integrate APVO436 into standard treatment regimens that inherently cause severe neutropenia," said Mr. Marvin White, President and CEO of Aptevo. "The initiation of Part 2 in our APVO436 study emphasizes our commitment to advance our ADAPTIR and ADAPTIR-FLEX platforms as integral parts of a novel standard of care for the most difficult-to-treat forms of cancer. We look forward to sharing interim data from Part 2 of the trial, later this year."

On May 27, 2021 Oasmia reported that Interim report for the period January 1, 2021 – March 31, 2021 (Press release, Oasmia, MAY 27, 2021, View Source [SID1234580672])

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SIGNIFICANT EVENTS DURING THE FIRST QUARTER
In January, Oasmia appointed Dr. Heidi B. Ramstad as Chief Medical Officer.
In March Fredrik Järrsten took up the position as Chief Financial Officer. Robert Maiorana, who has been acting CFO since December 2020, will continue as Head of Accounting for the company.
In March, Oasmia signed an agreement with Kazia Therapeutics, an Australian oncology-focused biotechnology company, to acquire exclusive global development and commercialization rights for Cantrixil, a product candidate in development intended for the treatment of ovarian cancer.
In March Oasmia entered into a collaboration agreement with Karolinska Institutet in Stockholm. The collaboration will generate new information for the potential development of new therapeutic APIs in various cancer indications.
In March, an arbitral tribunal in Stockholm upheld Oasmia’s right to record assignment of its patents and patent applications in its own name, which enables a faster re-registration process.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In April, Oasmia appointed Dr Reinhard Koenig as Chief Scientific Officer.
In April, Oasmia presented Cantrixil final Phase I data at the 2021 AACR (Free AACR Whitepaper) Annual Meeting.
In April, a Phase 1b trial of Oasmia’s Docetaxel Micellar in advanced prostate cancer was granted ethical committee approval by Swissmedic.
In April, Andrea Buscaglia was proposed as a new Board member by the Nomination Committee.
FIRST QUARTER: JANUARY 1, 2021 – MARCH 31, 2020
Consolidated net sales amounted to TSEK 37 (201,220)
Operating profit/loss was TSEK –40,843 (128,607)
Net profit/loss after tax amounted to TSEK –41,209 (124,706)
Earnings per share was SEK –0.09 (0.36)
CEO REVIEW – WELL POSITIONED FOR FUTURE GROWTH
Oasmia achieved several key goals in the first quarter, making further important progress in implementing the strategic transformation initiated when I joined last year.

A critical goal for Oasmia is to significantly expand our pipeline of development-stage oncology assets through M&A and in-licensing opportunities that we believe will fit with our strategic goals. This ambitious ’string of pearls strategy’ will capitalize on our proven oncology development and regulatory skills and expertise. We have a solid cash position to execute on the current strategy as laid out, with the possibility to reevaluate the financing need when these opportunities occur and with the progress of our development projects.

The acquisition of global development and commercialization rights for Cantrixil from Kazia Therapeutics in March was an exciting development for Oasmia and represented the first stage in this pipeline expansion – the first "pearl" added to our portfolio. The acquisition brings to us a promising clinical program in late-stage ovarian cancer, an area we know exceedingly well. In April, we presented final Phase I results for Cantrixil at the prestigious American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting. These highly promising results underscore our optimism about this program. Cantrixil is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse. In addition to its promise as stand-alone therapy, Cantrixil has the potential to complement Oasmia’s lead product for ovarian cancer, Apealea, through treatment protocols to be developed.

Since acquiring the rights to Cantrixil, we have been working to establish an advisory board of experts to provide input on the clinical development plan and have initiated discussions with regulators at the EMA and FDA. We have also made progress towards securing drug supply for forthcoming clinical trials.

Apealea (paclitaxel micellar), a non-Cremophor based formulation of paclitaxel, is Oasmia’s most advanced development program, approved in Europe and in development elsewhere for advanced ovarian cancer. Since it was out licensed to Elevar Therapeutics last year, we’ve been working closely with Elevar and its partners to support development and commercialization activities. Post period , in April, Elevar received notification from the FDA authorizing a pharmaco-kinetic study in the US. In parallel, preparations are being made for an additional clinical study. Both studies are intended to support an NDA application in the US.

We’re also pleased to report that Docetaxel micellar, a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication, has been granted ethical committee approval in Switzerland, paving the way for the Swiss Group for Clinical Cancer Research (SAKK) to initiate a Phase Ib trial in advanced prostate cancer.

Our technology platforms remain an important part of our business and complement our development and regulatory expertise. During the period we signed a collaboration agreement with the world renowned Karolinska Institutet here in Stockholm. The goal is to generate additional data to help us gain a deeper understanding of the potential of our proprietary XR-17 platform technology, with a focus on niche cancer indications. Over the longer term this will help us generate new pipeline candidates.

A vital part of our transformation is building a leadership team with the experience to drive our future growth. I’m pleased to say that with Fredrik Järrsten joining as CFO, and Heidi B. Ramstad and Reinhard Koenig’s appointments as CMO and CSO, we have completed our leadership team. This greatly strengthens our ability to execute our strategy and thrive as a business in the future.

Business transformations take time to achieve, but in 12 months we have put in place the right leadership team supported by a stronger Board with new expertise to take us to the next level of success. We have clearly defined and started executing on our strategy to become a leading cancer biopharma company with an emerging oncology pipeline. Thank you for your continued support during this period as we transition to an exciting future

On May 27, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that Susan Molineaux, Ph.D., the company’s founder, president and chief executive officer, will present at the Jefferies 2021 Virtual Healthcare Conference on Friday, June 4, 2021 at 9:00 am ET (Press release, Calithera Biosciences, MAY 27, 2021, View Source [SID1234580690]).

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A live audio webcast of the presentation can be accessed through the Investors section of the Company’s website at www.calithera.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.

On May 27, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following virtual healthcare Conference (Press release, FibroGen, MAY 27, 2021, View Source [SID1234580706]):

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Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 10:30 AM Eastern Time
Goldman Sachs 42nd Annual Global Healthcare Conference on Thursday, June 10, 2021 at 3:00 PM Eastern Time
A live audio webcast will be available on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for approximately 30 days.

On May 27, 2021 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, reported that a registrational clinical trial (GEMSTONE-301 study) of the anti-PD-L1 monoclonal antibody sugemalimab in patients with stage III NSCLC met its primary endpoint at a planned interim analysis reviewed by the independent Data Monitoring Committee (iDMC) (Press release, CStone Pharmaceauticals, MAY 27, 2021, View Source [SID1234583242]). The findings showed that sugemalimab as a consolidation therapy brought statistically significant and clinically meaningful improvement in the Blinded Independent Central Review (BICR) assessed PFS in patients with locally advanced/unresectable NSCLC without disease progression after concurrent or sequential chemoradiotherapy. Investigator assessed PFS showed consistent results as those of the primary endpoint. Sugemalimab was well-tolerated with no new safety signals. Subgroup analyses demonstrated that sugemalimab was associated with clinical benefit regardless of whether patients received concurrent or sequential chemoradiotherapy prior to sugemalimab.

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"Lung cancer is the leading cause of cancer-related mortality globally. There are currently few effective therapies for patients with stage III NSCLC whose disease did not progress after sequential chemoradiotherapy," said Professor Yi-long Wu of Guangdong Provincial People’s Hospital, the Leading Principal Investigator on the GEMSTONE-301 study," The successful results from the study indicate that sugemalimab will meet the urgent treatment needs of these patients."

"We are excited that sugemalimab becomes the first anti-PD-1/PD-L1 monoclonal antibody in the world to cover both stage III and stage IV NSCLC patients," said Dr. Frank Jiang, Chairman and CEO of CStone, "The continued success of sugemalimab in lung cancer demonstrates CStone’s leading research and development capabilities in the field of immuno-oncology. We are working closely with Pfizer and EQRx, our commercial partners for sugemalimab, on the next steps in our joint efforts to deliver this best-in-class drug to patients worldwide."

"Currently, there has not been an approved PD-1 or PD-L1 monoclonal antibody for treating patients in stage III NSCLC who have not developed disease progression after sequential chemoradiotherapy," said Dr. Jason Yang, Chief Medical Officer of CStone, "The GEMSTONE-301 is the first-in-class clinical study design that enrolled patients with either concurrent or sequential chemoradiotherapy to better reflect real-world clinical practice and cover a broader population. CStone is committed to providing treatment options to address the unmet medical needs. The GEMSTONE-301 study will advance the use of multidisciplinary treatment approaches in China to improve the quality of the diagnosis and treatment of stage III NSCLC. We will continue to explore the potential of sugemalimab in registrational clinical trials for patients with hematologic malignancies and advanced gastric and esophageal cancers."

CStone plans to submit an NDA to the NMPA for sugemalimab in stage III NSCLC, and will work with EQRx to hold regulatory discussions on the indications of stage III and stage IV NSCLC with regulators in multiple countries, including the U.S. Food and Drug Administration (FDA). Specific study data will be presented at an upcoming academic conference.

CStone formed a strategic collaboration agreement with Pfizer that includes the development and commercialization of sugemalimab in mainland China, and a framework to bring additional oncology assets to the Greater China market. CStone subsequently formed a strategic collaboration agreement with EQRx, under which EQRx licensed the exclusive rights to two key late-stage immuno-oncology assets, sugemalimab and CS1003 (anti-PD-1 antibody), for global development and commercialization outside of Greater China.

About NSCLC

In recent years, China has had rising lung cancer incidence. According to the latest estimates on the global burden of cancer released by International Agency for Research on Cancer (IARC), in 2020, an estimated 0.82 million new lung cancer cases and 0.71 million new lung cancer deaths occurred in China. Among all Chinese cancer patients, lung cancer is the leading cause of cancer-related deaths. NSCLC is the most common type of lung cancer.

There are currently limited treatment options for patients with locally advanced/unresectable (stage III) NSCLC. In China, sequential chemoradiotherapy is widely used , while concurrent chemoradiotherapy is with limited use. But both are with unsatisfactory efficacy.

About Sugemalimab (anti-PD-L1 antibody)

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduces the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials, including one Phase II registration studies for lymphoma (CS1001-201) and four Phase III registrational studies on stage III NSCLC, stage IV NSCLC, gastric cancer, and esophageal cancer, respectively.

CS1001-201 is a single-arm, multicenter, Phase II pivotal study designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). Based on the encouraging preliminary efficacy results, sugemalimab was granted Orphan Drug Designation for the treatment of T-cell lymphoma and Breakthrough Therapy Designation for the treatment of R/R ENKTL by the U.S. Food and Drug Administration. It has also been granted Breakthrough Therapy Designation by the National Medical Products Administration of China. The proposed indication is R/R ENKTL.

GEMSTONE-301 Study

GEMSTONE-301 study (clinicaltrials.gov registration number: NCT03728556; drug clinical trial registration number: CTR20181429) is a multicenter, randomized, double-blind Phase III clinical trial, designed to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with locally advanced/unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. The trial’s primary endpoint was PFS as assessed by BICR according to RECIST v1.1; the secondary endpoints included overall survival, PFS as assessed by investigators and safety profile.

GEMSTONE-302 Study

GEMSTONE-302 (clinicaltrials.gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) is a randomized, double-blind Phase III study, designed to evaluate the efficacy and safety of anti-PD-L1 monoclonal antibody sugemalimab combined with chemotherapy as the first-line treatment in naïve patients with stage IV non-small cell lung cancer (NSCLC) it vs. placebo combined with chemotherapy. The primary endpoint of the study was investigator-assessed PFS. Secondary endpoints included overall survival, BICR-assessed PFS and safety.

In August 2020, GEMSTONE-302 study met its primary endpoint of significantly prolonging progression-free survival (PFS) and reducing the risk of disease progression or death by 50% with sugemalimab combined with chemotherapy compared to placebo combined with chemotherapy, as assessed by iDMC at the planned interim analysis.

Subgroup analysis showed clinical benefit in patients with squamous versus non-squamous NSCLC, and in patients with PD-L1 expression >=1% versus PD-L1 expression <1%.

Sugemalimab in combination with chemotherapy was well tolerated, no new safety signals were identified. Specific study data were presented in a Proffered Paper Oral Presentation (Late-Breaking Abstract) at ESMO (Free ESMO Whitepaper) Asia 2020. In November 2020, the National Medical Product Administration of China accepted the New Drug Application for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer patients.